REporting recommendations for tumor MARKer prognostic studies (REMARK)
REporting recommendations for tumor MARKer prognostic studies (REMARK)
复制标题
DOI：
10.1007/s10549-006-9242-8
复制
发表时间：
2006-11-01
影响因子：
3.8
通讯作者：
Clark, Gary M.
中科院分区：
文献类型：
--
作者：
McShane, Lisa M.;Altman, Douglas G.;Clark, Gary M.
尽管对肿瘤标志物进行了多年的研究，并发表了数百篇关于肿瘤标志物的报道，但临床上有用的标志物数量少得可怜。通常，最初报道的一种标记的研究显示出很大的希望，但对相同或相关标记的后续研究得出不一致的结论或与有希望的结果直接矛盾。我们必须尝试理解为什么对同一标记物进行多项研究却得出不同的结论。各种各样的方法问题被用来解释这些差异。不幸的是，许多肿瘤标志物研究并没有以严谨的方式进行报道，发表的文章往往缺乏足够的信息来充分评估研究的质量或研究结果的普遍性。制定肿瘤标志物研究报告指南是2000年国家癌症研究所-欧洲癌症研究和治疗组织（NCI-EORTC）第一次国际癌症诊断会议的主要建议。对于成功的CONSORT随机试验倡议和诊断研究的STARD声明，我们建议指南提供有关研究设计、预先计划的假设、患者和标本特征、测定方法和统计分析方法的相关信息。此外，指南还建议在讨论中使用有用的数据和重要元素。这些准则的目标是鼓励透明和完整的报告，以便其他人可以获得有关资料，帮助他们判断数据的有用性，并了解结论适用的背景。
Despite years of research and hundreds of reports on tumor markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same marker lead to differing conclusions. A variety of methodologic problems have been cited to explain these discrepancies. Unfortunately, many tumor marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of tumor marker studies was a major recommendation of the National Cancer Institute-European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, pre-planned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply.